TetanusNCT07347938
A Phase 4 Study to Evaluate the Effectiveness and Safety of Siltartoxatug Injection for Tetanus Prophylaxis Following Injury
An observational study of Tetanus, run by Zhuhai Trinomab Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
Study sites were selected from hospitals across diverse regions of China. Approximately 6,000 participants who require passive immunization against tetanus due to various injuries (including those with severe wounds or heavily contaminated injuries) will be enrolled per clinical practice: Participants receiving… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tetanus
- What is being tested?
- Siltartoxatug Injection and HTIG/TAT/F(ab')₂
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 6,000 participants
- Where
- 1 siteChina
- Study dates
- 14 Jan 2026to 31 Mar 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults (≥18 years of age) who require passive immunization against tetanus following injury.
Who may be able to join
- Male or female aged ≥18 years.
- Receiving siltartoxatug for tetanus prophylaxis per its approved labeling, or receiving another passive immunizing agent (human tetanus immunoglobulin [HTIG], tetanus antitoxin [TAT], or equine F(ab')₂ fragment [F(ab')₂]) for tetanus prophylaxis per its labeling.
- Receiving or planned to receive standard wound management.
- Providing written informed consent by the subject or their legally authorized representative.
Who cannot join
- Life expectancy <3 months.
- Severe cognitive impairment or other condition interfering with the assessment of tetanus development.
- Currently participating in another interventional clinical trial (observational studies are permitted).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Mao Zhang, Doctor, +86 13757119125, zmhz@hotmail.com
About this study
Official title: A Multicenter, Prospective, Non-Randomized, Open-Label, Active-Controlled Phase 4 Study to Evaluate the Effectiveness and Safety of Siltartoxatug Injection for Tetanus Prophylaxis Following Injury
Study sites were selected from hospitals across diverse regions of China. Approximately 6,000 participants who require passive immunization against tetanus due to various injuries (including those with severe wounds or heavily contaminated injuries) will be enrolled per clinical practice:
Participants receiving siltartoxatug for tetanus prophylaxis and meeting eligibility criteria will be assigned to the siltartoxatug group (n=4,000); Participants receiving other passive immunizing agents (HTIG, TAT, or F(ab')₂) for tetanus prophylaxis and meeting eligibility criteria will be assigned to the control group (n=2,000), comprising approximately 1,000 HTIG recipients and 1,000 TAT/F(ab')₂ recipients. All clinical management decisions, including concomitant tetanus vaccination, will be made by investigators per standard clinical practice at each center.
- Conditions
- Tetanus
- Being tested
- Siltartoxatug Injection, HTIG/TAT/F(ab')₂
- Medical subject headings
- Tetanus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Siltartoxatug InjectionDrug
Dosage form: Injectable solution Strength: 10 mg / 0.5 mL per vial Route and regimen: Single intramuscular injection in the gluteal muscle at a dose of 10 mg
HTIG/TAT/F(ab')₂Drug
Dosage form, strength, and administration: As specified in the respective product's approved labeling (package insert). All use will follow routine clinical practice per local guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Siltartoxatug Injection | Participants receiving siltartoxatug for tetanus prophylaxis and meeting eligibility criteria will be assigned to the siltartoxatug group (n=4,000). Receives: Drug: Siltartoxatug Injection | |
| HTIG, TAT, or F(ab')₂ | Participants receiving other passive immunizing agents (HTIG, TAT, or F(ab')₂) for tetanus prophylaxis and meeting eligibility criteria will be assigned to the control group (n=2,000), comprising approximately 1,000 HTIG recipients and 1,000 TAT/F(ab')₂ recipients Receives: Drug: HTIG/TAT/F(ab')₂ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tetanus protection rate
Tetanus protection rate (1 - tetanus incidence rate) within 90 days post-dosing
Measured: within 90 days
Secondary outcomes (2)
Tetanus protection rate
Tetanus protection rate (1 - tetanus incidence rate) within 28 days and 130 days post-dosing
Measured: within 28 days and 130 days
Incidence rates of adverse events (AEs) and serious adverse events (SAEs)
Incidence rates of adverse events (AEs) and serious adverse events (SAEs)
Measured: within 130 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start14 Jan 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TetanusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhuhai Trinomab Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07347938
- Sponsor's protocol ID
- TNM002-401
- Status last verified
- Dec 2025
- First submitted
- 25 Dec 2025
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Non-Randomized, Open-Label, Active-Controlled Phase 4 Study to Evaluate the Effectiveness and Safety of Siltartoxatug Injection for Tetanus Prophylaxis Following Injury
- ClinicalTrials.gov ID
- NCT07347938
- Acronym / sponsor ID
- TNM002-401
- Conditions
- Tetanus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Zhuhai Trinomab Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Jan 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study sites were selected from hospitals across diverse regions of China. Approximately 6,000 participants who require passive immunization against tetanus due to various injuries (including those with severe wounds or heavily contaminated injuries) will be enrolled per clinical practice:
Participants receiving siltartoxatug for tetanus prophylaxis and meeting eligibility criteria will be assigned to the siltartoxatug group (n=4,000); Participants receiving other passive immunizing agents (HTIG, TAT, or F(ab')₂) for tetanus prophylaxis and meeting eligibility criteria will be assigned to the control group (n=2,000), comprising approximately 1,000 HTIG recipients and 1,000 TAT/F(ab')₂ recipients. All clinical management decisions, including concomitant tetanus vaccination, will be made by investigators per standard clinical practice at each center.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Siltartoxatug Injection | – | Drug: Siltartoxatug InjectionParticipants receiving siltartoxatug for tetanus prophylaxis and meeting eligibility criteria will be assigned to the siltartoxatug group (n=4,000). |
| HTIG, TAT, or F(ab')₂ | – | Drug: HTIG/TAT/F(ab')₂Participants receiving other passive immunizing agents (HTIG, TAT, or F(ab')₂) for tetanus prophylaxis and meeting eligibility criteria will be assigned to the control group (n=2,000), comprising approximately 1,000 HTIG recipients and 1,000 TAT/F(ab')₂ recipients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (≥18 years of age) who require passive immunization against tetanus following injury.
Key inclusion criteria (4 listed)
- Male or female aged ≥18 years.
- Receiving siltartoxatug for tetanus prophylaxis per its approved labeling, or receiving another passive immunizing agent (human tetanus immunoglobulin [HTIG], tetanus antitoxin [TAT], or equine F(ab')₂ fragment [F(ab')₂]) for tetanus prophylaxis per its labeling.
- Receiving or planned to receive standard wound management.
- Providing written informed consent by the subject or their legally authorized representative.
Key exclusion criteria (3 listed)
- Life expectancy <3 months.
- Severe cognitive impairment or other condition interfering with the assessment of tetanus development.
- Currently participating in another interventional clinical trial (observational studies are permitted).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Siltartoxatug InjectionDosage form: Injectable solution Strength: 10 mg / 0.5 mL per vial Route and regimen: Single intramuscular injection in the gluteal muscle at a dose of 10 mg | Drug | Siltartoxatug Injection |
| HTIG/TAT/F(ab')₂Dosage form, strength, and administration: As specified in the respective product's approved labeling (package insert). All use will follow routine clinical practice per local guidelines. | Drug | HTIG, TAT, or F(ab')₂ |
Primary outcome
Tetanus protection rate
Time frame: within 90 days
Tetanus protection rate (1 - tetanus incidence rate) within 90 days post-dosing
2 secondary outcomes
Tetanus protection rate
Time frame: within 28 days and 130 days
Incidence rates of adverse events (AEs) and serious adverse events (SAEs)
Time frame: within 130 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tetanus, run by Zhuhai Trinomab Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xia Qu, Master (+86 0756 726399, sammi.qu@trinomab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tetanus protection rate (time frame: within 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.